New videos highlight FDA expectations for running IND/IDE clinical trials

ReGARDD.org was recently updated with videos explaining IND/IDE sponsor and investigator responsibilities.

ReGARDD.org was recently updated with videos explaining IND/IDE sponsor and investigator responsibilities.

Along with other videos that explain exactly what ReGARDD is and how it can help you, there are 10 short videos each pertaining to IND and IDE studies. The videos review what the FDA expects from investigators and study teams who are running an IND/IDE clinical trial.

ReGARDD stands for “Regulatory Guidance for Academic Research of Drugs and Devices.” ReGARDD is a group comprised of regulatory affairs specialists and experts from North Carolina institutions that receive funding from the NIH Clinical and Translational Science Awards (CTSA) Program. Currently these institutions are the University of North Carolina at Chapel Hill (NC TraCS), Duke University, Wake Forest School of Medicine, and RTI International.

The ReGARDD website provides academic researchers with the regulatory tools and resources necessary to successfully navigate the pathway from discovery to clinical implementation of new drugs, biologics, and medical devices.

The website was also recently updated to include links throughout the site to provide visitors with further, detailed information on FDA.com.

Visit ReGARDD.org today.

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